Currentculinary health fundPolicy N/A

Denosumab products (Xgeva and biosimilars) utilization management

Defines prior authorization, coverage criteria, dosing, and exclusions for denosumab products indicated for prevention of skeletal-related events, giant cell tumor of bone, hypercalcemia of malignancy, and multiple myeloma; applies to medical benefit coverage decisions for covered members and providers.

Policy Summary

Payerculinary health fund

PolicyDenosumab products (Xgeva and biosimilars) utilization management

Policy CodePolicy N/A

Change TypeMultiple additions and clarifications (brands addedconcurrent-use restriction)

Effective DateN/A

Next Review DateMar 4, 2026

Key ActionObtain prior authorization and ensure prescribing is by or in consultation with a hematologist or oncologist.

SourceLink

POLICY UPDATE CHANGES

Aukelso (denosumab-kyqq) was added to the policy with the same criteria as other denosumab products.

Concurrent use with other denosumab products (e.g., Prolia) was added as a condition not recommended for approval.

Dosing language was changed to specify 'no more frequently' and 'subcutaneously' in dosing statements.

Wyost, Osenvelt, Bomyntra, Bilprevda, Xbryk, Xtrenbo were sequentially added to the policy with same criteria as Xgeva.

Policy name and wording were changed from 'Xgeva' to 'denosumab products (Xgeva)' to reflect inclusion of biosimilars.

9denosumab brands/biosimilars listed

1 yearauth duration (bone mets / MM)

120 mg

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Recommended Authorization and Coverage Rules

inv-01: Recommended Authorization Criteria (by indication)

Coverage of denosumab products (Xgeva, biosimilars) is recommended when the patient meets the conditions below for each indication.

Bone Metastases from Solid Tumors - Prevention of Skeletal-Related Events

Age: Patient is >= 18 years of age
Disease: Patient has bone metastases
Prostate cancer requirement: If patient has prostate cancer, it must be castration-resistant (progressed after hormonal therapy or surgical castration)
Examples of hormonal therapies listed in policy
Prescriber: Medication prescribed by or in consultation with a hematologist or oncologist
Dosing: 120 mg subcutaneously no more frequently than once every 4 weeks

Giant Cell Tumor of Bone: Approve for 1 year when treated adult or skeletally mature adolescent has unresectable disease or surgery would cause severe morbidity

Dosing: 120 mg subcutaneously no more frequently than once every 4 weeks with loading doses on Day 8 and Day 15 of Month 1

Hypercalcemia of Malignancy

Active malignancy: Patient has a current malignancy
Calcium threshold: Albumin-corrected calcium >= 11.5 mg/dL>= 11.5 mg/dL

Multiple Myeloma - Prevention of Skeletal-Related Events

Age: Patient is >= 18 years of age
Prescriber: Medication prescribed by or in consultation with a hematologist or oncologist

Coverage for denosumab products (Xgeva and biosimilars) is not recommended when requested for concurrent use with other denosumab products (for example, Prolia and its biosimilars). The prescribing information contains a warning that a patient receiving a denosumab subcutaneous injection should not receive other denosumab products concomitantly, and such requests may be denied.

This exclusion was added to the policy history to explicitly prohibit concurrent administration of distinct denosumab products and applies to medical benefit prior authorization decisions.

Coverage is not recommended for situations that are not explicitly listed in the Recommended Authorization Criteria. The policy will be updated if new published data change the criteria.

Providers seeking coverage for indications, dosing, or concomitant regimens not described in the authorization criteria should expect requests to be declined unless and until the policy criteria are revised to include those circumstances.

The policy specifically advises that concomitant administration of other denosumab products with Xgeva or its biosimilars is not recommended. The prescribing information contains a warning against receiving multiple denosumab products at the same time; therefore, combined use is considered potentially not medically necessary and may be a basis for denial.

When assessing prior authorization requests, reviewers should verify that the patient is not receiving another denosumab product concurrently and document why combined treatment would be clinically justified if it is proposed.

Codes and Clinical Values

Codes referencedmixed

No CPT/HCPCS/NDC codes listed

Document does not provide specific billing codes for denosumab products.

inv-06: Albumin-corrected calcium (cCa) — threshold value

Albumin-corrected calcium (cCa) threshold>= 11.5 mg/dL

Context for useRequired for Hypercalcemia of Malignancy indication (must be refractory to bisphosphonates)

Measurement noteThreshold refers to albumin-corrected serum calcium (cCa)

Prior Authorization, Prescribing, and Operational Notes

Prior Authorization

Prior Authorization Required

Prior Authorization Required — medical benefit coverage for denosumab products (Xgeva, biosimilars) is recommended. Approvals are provided for patients who meet the policy Criteria and Dosing and may be extended if the patient continues to meet those requirements. Requests for doses outside the established dosing will be reviewed case-by-case by a clinician (Medical Director or Pharmacist). All approvals are for the duration noted in the approval; when expressed in months, 1 month = 30 days.

Automation: None.
Approvals provided only when Criteria and Dosing are met.

Step Therapy

Step therapy / Dose Exceptions

No automated step therapy is in place. Requests for off-label dosing or doses outside the established dosing documented in the policy will be reviewed individually on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist).

Off-label dosing considered case-by-case.

Clinical Background

Denosumab products (Xgeva and biosimilars) are RANK ligand inhibitors indicated for: prevention of skeletal-related events in patients with bone metastases from solid tumors and in multiple myeloma, treatment of unresectable giant cell tumor of bone or where surgery would cause severe morbidity, and treatment of hypercalcemia of malignancy refractory to bisphosphonates.

These agents are administered by a healthcare provider via subcutaneous injection; dosing for most covered indications is 120 mg per administration given no more frequently than once every 4 weeks, with specified loading doses for certain indications and shorter authorization durations for hypercalcemia of malignancy.

Product Definitions

inv-12: Denosumab (Xgeva and biosimilars) — defined products

Reference productXgeva (denosumab)

Included biosimilars (policy lists)Aukelso; Bilprevda; Bomyntra; Osenvelt; Wyost; Xbryk; Xtrenbo

NotesProlia and its biosimilars (denosumab for osteoporosis) are mentioned but are not included under this policy

Initial Therapy Dosing and Authorization

inv-13: Initial therapy dosing and authorization

Initial approvals and dosing by indication.

Bone Metastases dosing: 120 mg subcutaneously no more frequently than once every 4 weeks; approve for 1 year

Prescribed by or in consultation with hematologist/oncologist; patient >=18

Giant cell tumor dosing: 120 mg subcutaneously no more frequently than once every 4 weeks with loading doses on Day 8 and Day 15 of Month 1; approve for 1 year

For adults and skeletally mature adolescents with unresectable disease or where surgery likely results in severe morbidity

Hypercalcemia dosing: 120 mg subcutaneously no more frequently than once every 4 weeks with additional 120 mg doses on Days 8 and 15 of first month; approve for 2 months

Albumin-corrected calcium >=11.5 mg/dL; patient has current malignancy

Continuation and Extension of Therapy

inv-14: Continuation/Extension — extended approvals criteria

Extended approvals.

Continuation: Extended approvals allowed if patient continues to meet Criteria and Dosing

Approvals provided for specified duration; months counted as 30 days

Step Therapy and Related Tables

Step	Requirement	Notes
1	No automated step therapy requirement	Prior authorization is recommended; requests for off-label doses or doses outside established dosing will be reviewed case-by-case by a clinician

Dosing Limits and Administration

inv-16: Denosumab products (Xgeva, biosimilars) — 120 mg per administration

Standard per-administration dose120 mg per administration

Maximum frequencyNo more frequently than once every 4 weeks (per dosing statements)

Administration routeSubcutaneous injection by a healthcare provider

Hypercalcemia dosing noteAdditional 120 mg doses given on Days 8 and 15 of first month for hypercalcemia of malignancy

Administration Setting

Note

Administer by healthcare provider via subcutaneous injection

Denosumab products should be administered by a healthcare provider via subcutaneous injection in an appropriate clinical setting such as an office, infusion center, or hospital outpatient department.

Xgeva is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally.

Biosimilars and Policy Inclusion

Billing Rule

Biosimilars included and follow Xgeva criteria/dosing

Biosimilar denosumab products are included in this policy and follow the same criteria and dosing as Xgeva; biosimilars listed in the policy have been added with the same criteria as Xgeva.

Policy lists multiple biosimilars (e.g., Aukelso, Bilprevda, Bomyntra, Osenvelt, Wyost, Xbryk, Xtrenbo) treated under the same criteria as Xgeva.